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Patient advocate Bob Klein inspired, led, and helped raise $30 million to pay for the campaign to pass Proposition 71, which became the California stem cell program.

Patient advocates like my paralyzed son, Roman Reed, sat in wheelchairs on street corners, gathering 1.2 million signatures to get Prop 71 on the ballot.

Patient advocates have defended the California Institute for Regenerative Medicine at every step, including fighting for decent salaries for staff and leadership, so they would be paid well, instead of just adequately.

So why would anyone want to silence patient advocate voices now-- especially when their support will be crucial if there is to be a continuation of the program?

REMOVE PATIENT ADVOCATE VOICES FROM THE CALIFORNIA STEM CELL PROGRAM?

By Don C. Reed

What group of people was Proposition 71, the California stem cell program, designed to help?

Patients with incurable disease or disability.

Who speaks for them? They do, and we do—the patients themselves and those who advocate on their behalf.  Patient advocates are people like my son Roman, who in his wheelchair, helped gather 1.2 million signatures to get the Initiative on the ballot.

 Patient advocate Bob Klein inspired, led, and helped raise the $30 million to pay for the campaign; patient advocates defended the program at every step, including fighting for decent salaries for staff and leadership, so they would be paid well instead of adequately.

So why should anyone want to silence patient advocate voices now—especially when their support will be crucial if there is to be a continuation of the program?

January 23rd, 9-5, an all-day meeting on the future of the California stem cell program will be held at the Claremont Hotel in Berkeley, California. Check with www.cirm.ca.gov for official announcements. (Neither my notification here, nor my comments should be taken as official-- I love the program but am only a supportive citizen.)

The meeting will focus on a recently completed “study” of the California stem cell program.

The entire 166 page report, “Committee on a Review of the California Institute for Regenerative Medicine (CIRM): Board on Health Sciences Policy; Institute of Medicine” is available at http://www.nap.edu/....

I consider both the study and its recommendations staggeringly misguided.

 If its recommendations were enacted, they would silence stem cell patient advocate involvement, eliminate public debate on funding proposals, and delegate the real decisions to secret proceedings by an out-of-state-controlled board.

It would no longer be the program California voted into law.

Presently, patient advocates are both members of the board of directors, and welcome members of the public. Our voices are respected and routinely heard; we are welcome at the table when decisions are made.

This is something wonderful, which would be destroyed if the study’s recommendations were adopted wholesale.

The study was authored by a 13-member panel which had just one stem cell scientist, zero patient advocates, no biotech representatives, and precious little understanding of Proposition 71’s place in California law. http://voterguide.sos.ca.gov/...

It feels so one-sided: with opponents of the program featured prominently, and their opinions given credence.  

Where are the 200-plus major organizations representing literally millions of Californians and Americans who support our program? Where are the viewpoints of the California Medical Association, the Coalition for the Advancement of Medical Research, the California Children’s Hospital, the Chambers of Commerce, Bay Bio, the International Society for Stem Cell Research, just to name a few?  

The IOM’s objections to California’s program may be summed up in two sentences:

“They (the governing board) make proposals to themselves…regarding what should be funded. They cannot exert independent oversight.”—Walter Shapiro, Chair of the study.

 This is demonstrably false.

Members of the governing board NEVER “make proposals to themselves”. They are prohibited by law from so doing. In fact, they may not even voice an opinion on any project which might benefit their parent organizations.

Here is how it actually works: scientists offer proposals, which are evaluated by the grants working group, (GWG), with  a majority of out-of-state stem cell experts.

After being scored, the projects are brought before the 29-member Independent Citizens Oversight Committee (ICOC) for a public hearing.

Typically the grant proposals fall into three categories:  recommended, maybe, and not.

The project names and scores are put up on a screen so everyone can see. Then the chair will ask: does anyone believe a particular grant proposal is in the wrong category?  

In the overwhelming majority of cases, as high of 90% of the time,  the ICOC agrees with the recommendations.  

But when a board member disagrees with a score, he or she may ask that it be publicly discussed.   Also, the grant applicants themselves can submit a petition pointing out errors in the scientific critique.  They are allowed three minutes to state their case.

The CIRM scientific staff gives its opinion, in support or opposition.  

 The board gives its comments-- and we in the public are allowed to offer support or objections—our only opportunity to do so.

Underline that in your mind: this is the patient advocates’ only chance to influence a decision on what shall be funded. Take it away, and we might as well just go home—after doing the work to make the program possible, we would have been shut out.

After this, the board votes.

Instead, the IOM recommendations would silence both the governing board AND  patient advocates.

The board would only be allowed to vote yes-or-no on the entire slate of grants. What are they going to say? No, don’t let anything go forward? They would be reduced to a rubber stamp.

No public discussion would be allowed on individual grants.  

Not only would this remove patient advocates, educators, biomedical authorities and ethicists from significant input, it would also violate California law: resulting in the real decisions being made in secret, by the out-of-state controlled Grants Working Group.

This is unacceptable.

The patient advocacy community provide real-life insights on current therapies and policies. No one knows better what patients need to sustain both life and the quality of life—and who better to be heard on the risk/benefit decisions when a new drug or therapy might be tried?

A few days ago, a grant to fight thalassemia and sickle-cell anemia was approved for funding: these diseases disproportionately affect African-American and Asian-American communities. What if that grant had been turned down? Should the public have no avenue to voice our concerns?

Yet the IOM proposal would deny our voice. Why?

The study labels the patient advocates as biased because we want cures for ourselves or our loved ones. Because we are affected, we are ineligible as part of the solution?

“No taxation without representation” would seem to apply here. Those who want our help must accept our intelligent  involvement.  

There was a time when patients passively accepted doctoral decisions as from on high.

California today takes a different approach. Here, patients and advocates are active partners in the stem cell program we built.  

Do others consider patient advocates useful? Listen to the U.S. Food and Drug Administration.

The “FDA includes Patient Representatives (with voting rights—dr) on advisory committee panels that review products and therapies related to serious and life-threatening diseases...” --http://www.fda.gov/...

The IOM report considers the governing board itself to be biased because its members were chosen from leaders of colleges, research institutions, the biomed industry, and other organizations, including ten patient advocates from various disease areas.

This is a convergence of expertise, not a conflict of interest.  Our Initiative was always intended to be led by experts from the scientific and medical fields. When we were sued by the Religious Right, this very issue was part of their attack—and it was defeated. Having experts on a board is nothing shocking. Scientists from prestigious research institutions serve on National Institutes of Health (NIH)  peer review panels. Are they biased too?  The IOM seems to want board members to have no connection with either science or chronic illness—should ignorance be considered an advantage?

The IOM study goes so far as to recommend “Elimination of the current process in which applicants rejected by reviewers appeal publicly to the governing board. …. Instead appeals would be heard only by staff BEHIND CLOSED DOORS.” (emphasis added)

More secrecy, instead of open argument?

The IOM would actually deny board membership to anyone with a “personal conflict”  meaning someone in their  family had an incurable illness, because that might influence their vote. What nonsense is that?

First, it is hard nowadays to find a person who does not a family member suffering a chronic disease or disability. My son is paralyzed, my sister has cancer, my brother has a permanently crippling leg injury—so I would be disqualified—three times!  

We need people on the board who care passionately about fighting disease and disability, people who know what it means to have a loved one at risk—that is why we are fighting!

The report does admit the California program made tremendous achievements, saying:

 “bold social innovation… enhances  California’s position as one of the key international hubs of activity in regenerative medicine…impressive research portfolio…enriches regenerative medicine everywhere…sets in motion a significant scientific enterprise… an impressive grant management structure… exemplary training program… a pipeline of intellectual property… translational projects primed for industry involvement.”

There we agree. The California stem cell program is indeed something fantastic; it works. So why mess with it, in such a brutal and insulting manner?

If you have an opinion on this subject, join us at the public workshop at the Claremont Hotel, Berkeley, January 23rd, 9-5. If you want to be heard, be there.

At this all-day meeting, the proposals of the IOM will be considered, both in regards to California law (to this non-lawyer some of the changes appear illegal), and the voter-approved structure of Proposition 71, as written in the California Constitution.

As it does with all serious criticisms, the Independent Citizens Oversight Committee will study the IOM opinions carefully. Where improvements can be implemented without compromising the integrity of our program, they will be made.

But the open and interactive structure of this magnificent program must not be destroyed.

Originally posted to diverdonreed on Wed Dec 19, 2012 at 11:17 AM PST.

Also republished by California politics.

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